Bedside Silo Versus Operative Closure for Gastroschisis

This study has been terminated.
(Change in referral pattern changed the population we were studying)
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00404690
First received: November 27, 2006
Last updated: March 2, 2009
Last verified: November 2007
  Purpose

The hypothesis is that there is no difference between bedside silo placement and operative closure in return of bowel function, ventilator dependence, or length of stay.

The primary outcome variable between the two techniques will be determined from this study that can then be used to develop a definitive study. The likely variables will be length of time to meet discharge criteria, length of hospitalization, time to full feedings, time on mechanical ventilation and total hospital charges.


Condition Intervention
Gastroschisis
Procedure: Bedside Silo
Procedure: Operative attempt at closure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bedside Silo Versus Attempted Operative Closure for Gastroschisis: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • this is a pilot study therefore there is no primary outcome variable [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Time to full feeds, time of ventilation, hospital charges, total time in the operating room, number of operations, fluid resuscitation, total transfusion volume, fluid re [ Time Frame: 1 year ]

Estimated Enrollment: 20
Study Start Date: October 2006
Estimated Study Completion Date: October 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Operative attempt at closure
Procedure: Operative attempt at closure
go the operating room to attempt closure
Experimental: 2
bedside silo
Procedure: Bedside Silo
silo placed at bedside on admission

Detailed Description:

A strategy of blocked randomization will be utilized. The randomization will be blocked in groups of 4. Randomization sequence will be kept by the principal investigator. After permission is obtained, the next assignment will be obtained. This method assures that the physician obtaining permission will be blind to the treatment group.

The treatment groups will consist of the same medical management, feeding regimen and discharge criteria.

The interventions will be either bedside silo or operative attempt at closure. During attempt at primary closure, the abdomen will be closed completely if the staff anesthesiologist and surgeon agree the belly is not too tight based on ventilatory parameters, vital signs and appearance. If either the surgeon or anesthesiologist should feel the closed abdomen is too tight, a ringed silo will be placed in the operating room, the same silo used in the bedside treatment arm, and the child will continue in the study. When a silo is placed either in the operating room due to inability to close the abdomen or at the bedside, they will be managed the same way. The skin will be dressed in the standard fashion (betadine jelly, xeroform and kerlix). The dressing allows visualization of the bowel. No reductions will be done the day of placement. After one night of observation a tie will be gently placed to apply downward pressure on the bowel. This pressure will not be allowed to increase the peak ventilator pressure by more than 2 cm H2O. One tie will be placed each subsequent day until the tie is within 2 cm of the skin at which point the patient will be scheduled for operative closure the day following the placement of the tie.

The medical management is controlled for resuscitation, sedation, ventilation and feeding between groups.

  Eligibility

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with gastroschisis

Exclusion Criteria:

  • Born prior to 34 weeks estimated gestational age
  • Another congenital anomaly influencing the respiratory status, gastrointestinal status, or the length of hospitalization and recovery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404690

Locations
United States, Missouri
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Shawn D St. Peter, MD The Children's Mercy Hospital
  More Information

No publications provided

Responsible Party: Shawn St. Peter, Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00404690     History of Changes
Other Study ID Numbers: 06 09 141
Study First Received: November 27, 2006
Last Updated: March 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Gastroschisis
Silo
Operative closure

Additional relevant MeSH terms:
Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 01, 2014